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临床试验/CTRI/2017/08/009503
CTRI/2017/08/009503已完成未知

Evaluation of dermatological safety ofInvestigational products by primary irritationPatch test on subjects with sensitive skin

ITC Limited ITC Life Sciences Technology Centre0 个研究点目标入组 24 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1)Healthy male and female subjects in the age group of 18-55 years (both age
  • 2)Subjects in good general health
  • 3)Subjects with Fitzpatrick skin phototype III to V
  • 4)Subjects scoring greater than 30 for section 2- sensitive v/s resistant skin in modified Dr. Baumannââ?¬•s skin type questionnaire
  • 5)Subject identified to have sensitive skin basis dermatologistââ?¬•s assessment of
  • skin with fine texture and closeness of blood vessels to the surface
  • 6)Subjects willing to give a voluntary written informed consent
  • 7) Subjects willing to maintain the test patches in designated positions for 24
  • 8)Subjects willing to come for regular follow up visits
  • 9)Subjects ready to follow instructions during the study period
  • 10) Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results

排除标准

  • 1) Subjects with a present condition of allergic response to any cosmetic product on the test area
  • 2)Subjects under chronic medication (e.g. antihistamines, antifungals, corticosteroids,
  • topical steroids, etc.) that might influence the outcome of the study
  • 3)Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the
  • determination of Pregnancy)
  • 4) Subjects suffering from any cutaneous disease that could interfere with the study
  • 5) Subjects suffering from any chronic illness that may influence the cutaneous state or
  • any other illness including Diabetes, liver disease, HIV or any other serious medical
  • 6) Subjects participating in any other cosmetic or therapeutic trial
  • 7) Subjects having participated in a similar investigation in the past four weeks

研究者

发起方
ITC Limited ITC Life Sciences Technology Centre

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